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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002941-39 | EudraCT Number | EudraCT |
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The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Experimental | faldaprevir medium, fasted |
|
| Test 1 | Active Comparator | faldaprevir medium, fed |
|
| Test 2 | Active Comparator | faldaprevir medium + omeprazole medium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| faldaprevir | Drug | medium dose of faldaprevir |
| |
| faldaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
| Faldaprevir: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the faldaprevir in plasma In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy condition
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.59.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
This was a randomised open label, 3-way cross over study with three sequences. Faldaprevir administrations in each treatment period were separated by washout period of at least 14 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed | Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration. Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir. Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less. |
| FG001 | Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP | Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less. Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment) faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir. |
| FG002 | Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir | Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir. Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less. Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS) including all subjects who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment) Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less. Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir. Drug administrations were separated by a washout period of at least 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | [ng*h/mL] | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
|
From first drug administration until the end of trial visit, up until 20 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Faldaprevir in Fasting | Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
medium dose of faldaprevir |
|
| omeprazole | Drug | medium dose of omeprazole |
|
| faldaprevir | Drug | medium dose of faldaprevir |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Faldaprevir After a High-fat Meal | Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less |
| OG002 | Faldaprevir and Omeprazole | Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir |
|
|
|
| Primary | Faldaprevir: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the faldaprevir in plasma In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
|
|
|
|
| Secondary | Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration |
|
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Faldaprevir After a High-fat Meal | Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less | 0 | 14 | 4 | 14 |
| EG002 | Faldaprevir and Omeprazole | Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast | 0 | 14 | 4 | 14 |
| EG003 | Omeprazole | 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir | 0 | 15 | 0 | 15 |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| ANOVA | Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting | 0.2204 | Geometric Mean Ratio | 93.55 | Standard Deviation | 53.0 | 2-Sided | 90 | 65.783 | 133.030 | Standard deviation is actually the geometric coefficient of variation (gCV) | Yes | Non-Inferiority or Equivalence | no formal testing, investigation of bioavailability |
| ANOVA | Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting | 0.0946 | Geometric Mean Ratio | 94.72 | Standard Deviation | 31.4 | 2-Sided | 90 | 76.25 | 117.67 | Standard deviation is actually the geometric coefficient of variation (gCV) | Yes | Non-Inferiority or Equivalence | no formal testing, investigation of bioavailability |